show episodes
 
Welcome to the "Speaking of Wealth" podcast showcasing profit strategies for speakers, publishers, authors, consultants, and info-marketers. Learn valuable skills to make your business more successful, more passive, more automated, and more scalable. Your host, Jason Hartman interviews top-tier guests, bestselling authors and experts including; Dan Poynter (The Self-Publishing Manual), Harvey Mackay (Swim With The Sharks & Get Your Foot in the Door), Dan Millman (Way of the Peaceful Warrior) ...
 
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show series
 
Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group. Listen as Mitch shares his unique in…
 
What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO). Together, Isabella and Jo…
 
Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible. In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP o…
 
It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention. In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant. Together, Mike and Jon tal…
 
"And she remakes the wedding dress, and I don't know how she does this, but out of that material she's able to make a top hat." Josh comes back to represent redheads and we talk three ginger movies! 0:00 -- Intro (Josh, vax news, Oscar news) 7:54 -- The Quiet Man 30:06 -- Betsy's Wedding 49:10 -- Zero Dark Thirty 1.19:10 -- Awards and rankings 2.08…
 
Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice? The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. In this specia…
 
Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement. In this episode of the Global Medical Device Podcast, Jon Speer talk…
 
What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device? In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS). Jon and Milton discuss practical pointers for determining and describing th…
 
For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seiz…
 
"That's his thing -- he likes to eat cities and princesses." Three or four years of anticipation are satisfied as we finally speak of Greek tales thousands of years old (or at least from the Italian Film Commission 67 years ago). Andy from Kiss Your Franchise Goodbye completes his required double stint of servitude. Also, as a special guest our old…
 
Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them? In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet…
 
Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy …
 
The one person you have the most trouble forgiving is yourself. Yet much of the way we think and act was learned before we reached the age of 10. Randy Gage, author of the new book Radical Rebirth, joins Jason Hartman to discuss how we can constantly reinvent ourselves to become the best version we can possibly be. Key Takeaways: [1:30] Randy's on …
 
Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the uni…
 
How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences? In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems co…
 
"What cuddly animal is killed when your hands are full too often?" Andy from Kiss Your Franchise Goodbye is back with an Italian vendetta and three movies that made him the cuddly man he is today. They're pretty alright movies. 0:00 -- Intro (Andy is back, near picks) 14:53 -- A Hard Day's Night 53:35 -- The Godfather: Part II 1.36:03 -- Your Name.…
 
Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds v…
 
Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier. In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, …
 
Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why t…
 
Why is design, manufacturing, quality, and culture so important in the medical device industry? These key elements must exist and function in synchrony so that a medical device can save and improve patient lives. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufact…
 
What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible? In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answer…
 
"Is that the most 80s thing ever? To be married to Robert Wagner?" Mark joins again. Death and laughter ensue with three movies where the star died before filming completed. This unlithe podcast runs over three hours, so hopefully you have a real boring workday goin' on right now. Hey how did we not pick North Carolina as best recurring character? …
 
One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenligh…
 
What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan. In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon an…
 
What makes Greenlight Guru unique? It’s Guru Edge⁠—a team of medical device professionals with a ton of industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Karen Schuyler, a Medical Device Guru at Greenlight Guru with nearly 15 years of experience working in the medical device industry. Listen as Karen offe…
 
Jason Hartman talks with the author of 17 great books, Jeffrey Gitomer. Jeffrey's latest book, Go Live!, is a salute to mastering the virtual world and exuding comfort on video. If you don't master virtual and you don't master video, someone else will. Jeffery, the self-branded 'king of sales,' gives top tips from his book on how to be a thought le…
 
Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedures, or its manufacturer. In this episode of the Global Medical Device Podcast, Jon Speer talks to Annie Campbell and Emily Holden from Now Medical Studios, where they create medical illustrations and animations for the heal…
 
Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firstha…
 
How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectivel…
 
The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medi…
 
"It was as overwhelming as, like, Dorothy Gish complimenting you?" Josh Fillmore is back to talk about movies with title colors spanning the rainbow! We go from red to white and then all the way back to red! Dancing! Crime wife abuse! Nuclear subs! 0:00 -- Intro (Josh is back, brrrr, the podcast cost) 7:23 -- The Red Shoes 30:40 -- White Heat 55:28…
 
Nick Loper of Side Hustle Nation joins Jason Hartman to discuss three different business models, from sales to services, everything from knife sharpening to pooper scooping. Build a side hustle to fund your vacation or fund your next investment property. Nick Loper is host to a podcast and author of a couple of books. His creative approach to build…
 
What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible. In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years wort…
 
Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one of the most important things a medical device company can do to be successful.In this episode of the Global Medical Device Podcast, Jon Speer talks to Ed…
 
"It's his severance meat." Josh comes back with his personal three movies that made him the man he is today. Incidentally, he's now a boxing French lawyer. Also big apologies for dealing with some real heavy material and then getting all frivolous as usual about it because that's what we know. 0:00 -- Intro (Josh is back, movie intro, Roy's AMC mem…
 
Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled to, is left on the table.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the importance of medical device reimbu…
 
"It's like children. Once you've got more than two, it doesn't matter." We're talking Dick! Philip K. Dick! No guests! 0:00 -- Intro (no guest, Kirk Van Houten, intro to Dick) 9:25 -- Total Recall 33:14 -- Minority Report 58:58 -- The Adjustment Bureau 1.20:46 -- Awards and rankings 1.55:23 -- Future business 2:08:24 -- Outro and outtakes Hey! Be s…
 
Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-19 testing technologies that shorten viral detection cycles and increase access to reliable, accurate testing on a widespread scale.In this episode of the…
 
What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about CDRH’s previous, current, and future strategic priorities, incl…
 
What’s the relationship between product feedback, complaints, and adverse events?In this episode of the Global Medical Device Podcast, Jon Speer talks to guest Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research (CRO).Jon and Isabella discuss some important processes and methods medical device companies should consider for…
 
New Year, New Goals, Same proven asset class! Jason Hartman invites you to celebrate with him another fantastic year of prosperity for all real estate investors practicing some of Hartman’s proven investment techniques. Following the celebration, we must look for the “what next” plan or goal. How do you build your goals? Do you write them down? Do …
 
The curtain falls and is burned on Discovery season 3! Season 3 we hardly knew ye! Podcast breakdown: 0:00 -- nuqneH (movies; Star Trek; Kiss Your Franchise Goodbye; Yours, Mine, & Theirs; phone number) 10:45 -- "Su'Kal" 20:25 -- "There Is a Tide..." 31:02 -- "That Hope Is You, Part 2" 46:20 -- Curse of the Azure Bonds side talk 52:40 -- Podcast aw…
 
"So like, every movie that's in a major city in the 60s and 70s I feel like just by watching the movie I'm going to get an STD." Andy's back to talk winning antagonists! By a miraculous coincidence the movies mean too much to us to contain within a mere three hours. 0:00 -- Intro (Andy Wilson welcome, Kiss Your Franchise Goodbye, J.R. Watches Star …
 
What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device industry thus far? Have the emergence of these new technologies created new, unanticipated regulatory and quality challenges for industry professionals?In this episode of the Global Medical Device Podcast, host Jon Speer and guest Mike Drues from Vascul…
 
Jason Hartman discusses the 12 days of Christmas with one caveat: inflation adjustments! First, let us all rediscover the true meaning of Inflation. This year, Inflation for the 12 days of Christmas has some peculiar changes, thanks largely to social distancing. Will we get a second stimulus? If so, how much will it be? Does your investment produce…
 
Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal.In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device i…
 
Big pre-Christmas episode! Five big ones from Discovery season 3! Podcast breakdown: 0:00 -- nuqneH (Christmas, Christmas cards (lack of), Boba Fett, Yours, Mine, & Theirs ) 21:44 -- Viewer mail 24:57 -- "Scavengers" 35:04 -- "Unification III" 48:33 -- "The Sanctuary" 1.03:00 -- "Terra Firma, Part 1" 1.09:57 -- "Terra Firma, Part 2" 1.20:30 -- Mini…
 
The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transiti…
 
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